Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2006-03-31

Brief Summary

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Despite experts' recommendations, the consumption of Fresh frozen plasma (FFP) is very heterogeneous among French cardiac surgery centers. This probably reflects heterogeneous practices that are not characterized and whose outcomes on morbidity and mortality are not documented.

The principal objective of the study is to describe transfusional strategies of FFP in patients undergoing cardiac surgery. The other objectives are: to assess the conformity of FFP transfusion or lack of transfusion to current French authorities' recommendations, to describe the post-operative mortality and morbidity and to assess the prognostic role of FFP on mortality and morbidity. Prognostic analyses will take into account other prognostic factors of mortality and morbidity.

1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or transfused with FFP without bleeding) will be included in the study.

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Detailed Description

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Background

Fresh frozen plasma (FFP) transfusions recommendations are essentially based on experts' opinions. However, disparity in consumption of FFP by cardiac surgery centers in France probably reflects heterogeneous practices that are not well characterized. Furthermore, health outcomes of these strategies on morbidity and mortality are not documented.

Objectives

Primary: to describe transfusional strategies of FFP in patients undergoing cardiac surgery and either presenting a serious bleeding during pre, per or post-operative periods or transfused by FFP without a serious bleeding.

Secondary:

* To estimate the conformity of transfusion or lack of transfusion of FFP to French authorities recommendations.
* To describe the post-operative mortality and morbidity.
* To evaluate the prognostic role of FFP transfusion on mortality and morbidity

Study design

Prospective prognostic cohort study, with an exhaustive recruitment in participating cardiac surgery centers during the study period.

Eligibility criteria

Centers: 16 French cardiac surgery centers.

Patients:

* Coronary artery bypass grafting (CABG), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft.
* Serious bleeding or FFP transfusion during pre, per or post-operative period.
* Patient's consent for collecting medical data

Analysis

Descriptive analysis of transfusional strategies according to patients' characteristics, type of surgery and circumstances of transfusions.

Conformity to French authorities' current recommendations. Multivariate analysis of the prognostic role of FFP transfusion on 30-day mortality.

Conditions

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Heart Surgery Blood Loss, Surgical

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Fresh Frozen Plasma (blood product)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Coronary artery bypass grafting (CABG), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft.
* Serious bleeding or FFP transfusion during pre, per or post-operative periods.
* Patient's consent for collecting medical data